Phasix 1191025Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741107580), received between Apr 30, 2019 and Feb 5, 2025 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL (B)(4). THE SUBJECT PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, WITH CONCOMITANT HYSTERECTOMY & OOPHORECTOMY WITH IMPLANT OF PHASIX MESH AS AN ONLAY ON (B)(6)2024. THE MESH WAS TRIMMED TO 22CM AND CLOSED WITH ABSORBING MONOFILAMENT SUTURE; PATIENT WAS DISCHARGED ON (B)(6)2024. THE SUBJECT PATIENT RETURNED FOR 1ST POST-OP VISIT ON (B)(6)2025, WAS DIAGNOSED WITH UTI AND WAS PRESCRIBED CIPRO AND LATER BACTRIM. THE PATIENT PRESENTED TO THE ED ON (B)(6)2025, WITH NOTED DRAINAGE AND DISCHARGE FROM THE SURGICAL INCISION SITE; UPON ARRIVAL, WOUND CULTURES WERE COLLECTED. CT DEMONSTRATED POSTOPERATIVE SEROMA VERSUS AN ABSCESS. THE SUBJECT'S INCISION WAS OPENED AT THE BEDSIDE, AND WET & DRY DRAPES WERE APPLIED. THE PATIENT WAS ALSO MANAGED WITH A CEFEPIME AND VANCOMYCIN AND THERE WAS NO PLAN FOR IR DRAINAGE. THE SUBJECT HAD ADDITIONAL WOUND PACKING ON (B)(6)2025 AND WAS PLANNED FOR DISCHARGE WITH HOME NURSING SCHEDULED FOR AT-HOME WOUND CARE. THE ADVERSE EVENT RESOLVED ON 14-JAN-2025. THE REPORTED ADVERSE EVENT (SEROMA) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE, POSSIBLY RELATED TO THE PROCEDURE AND HAS RECOVERED/RESOLVED. THE AE HAS

  Patient problems: Seroma

  MAUDE report 21311667 ↗
• InjuryMay 9, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  EVENT REPORTED PER THE CLINICAL TRIAL DVL-HE-018: THE SUBJECT PATIENT UNDERWENT AN OPEN RELAPAROTOMY WITH COLECTOMY CONCOMITANT OSTOMY CREATION/REVISION/REVERSAL AND FISTULA TAKEDOWN PROCEDURE ON (B)(6) 2023, DURING WHICH A PHASIX MESH WAS TRIMMED, PLACED IN ONLAY FASHION, AND SECURED IN PLACE WITH ABSORBABLE MONOFILAMENT 3-0 VICRYL SUTURES. A 3 CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH SLOW ABSORBABLE MONOFILAMENT 1-0 PDS SUTURES. THE PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2023. ON (B)(6) 2024, THE SUBJECT PATIENT EXPERIENCED ABDOMINAL PAIN. IT WAS REPORTED THAT THE PATIENT UNDERWENT CT SCAN AND MEDICATION (IV HYDRATION, ANTIEMETIC, ANALGESIC) WAS PROVIDED. NO ACTION WAS TAKEN TO THE STUDY DEVICE. THE PATIENT WAS DISCHARGED WITH BENTYL AND ZOFRAN. AS REPORTED, THE REPORTED ADVERSE EVENT (ABDOMINAL PAIN) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE AE HAS BEEN ASSESSED AS MILD IN SEVERITY. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).

  Patient problems: Abdominal Pain

  MAUDE report 19277755 ↗
• InjuryFeb 27, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER THE CLINICAL TRIAL (B)(4) : THE SUBJECT PATIENT UNDERWENT A LAPAROSCOPIC PRIMARY LAPAROTOMY MESENTERIC LYMPH NODE INCISION AT UMBILICUS WITH CONCOMITANT PROCEDURES OOPHORECTOMY, SMALL BOWEL RESECTION AND LIVER BIOPSY ON (B)(6) 2024, DURING WHICH A PHASIX MESH WAS TRIMMED, PLACED IN ONLAY FASHION, AND SECURED IN PLACE WITH ABSORBABLE MONOFILAMENT 3-0 PDS SUTURES. A 3 CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH SLOW ABSORBABLE MONOFILAMENT 1 PDS SUTURES. SKIN CLOSURE WAS ACHIEVED BY USING SUTURES AND SURGICAL GLUE. ON (B)(6) 2024, PATIENT WAS DIAGNOSED WITH INFECTION, ABSCESS AND UNDERWENT SURGERY TO REMOVE FLUID COLLECTION ABOVE THE PHASIX MESH. THE PHASIX MESH WAS INTACT AND THE INCISION FROM THE SURGERY IS PARTIALLY CLOSED TO LEAVE ONE AREA OPEN FOR PACKING. THE PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2024. THE REPORTED ADVERSE EVENT (INFECTION, FLUID COLLECTION/ABSCESS) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE, POSSIBLY RELATED TO PROCEDURE, AND RECOVERED/RESOLVED. THE AE HAS BEEN ASSESSED AS SEVERE IN SEVERITY. THE REPORTED AE DOES MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVEN

  Patient problems: Abscess; Bacterial Infection; Hernia; Unspecified Infection

  MAUDE report 18788876 ↗
• MalfunctionAug 21, 2023Expiration Date Error; Expiration Date Error

  AS REPORTED, ON (B)(6) 2023 THE PATIENT UNDERWENT A BILATERAL BREAST IMPLANT REMOVAL RECONSTRUCTION AND RECTUS MYOCUTANEOUS FLAP ABDOMINAL WALL REPAIR WITH PHASIX MESH. IT WAS LATER NOTED THAT THE LABELED EXPIRATION DATE FOR THE PHASIX MESH WAS 28-JUL-2023. THERE HAS BEEN NO MEDICAL OR SURGICAL INTERVENTION, SURGEON WAS NOTIFIED AND NOT CONCERNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17587620 ↗
• InjuryAug 11, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER THE CLINICAL TRIAL (B)(4): ON (B)(6) 2021 THE SUBJECT PATIENT UNDERWENT RIGHT-HAND ASSIST LAPAROSCOPIC RADICAL NEPHRECTOMY, OPEN REPAIR DURING WHICH A PHASIX MESH WAS TRIMMED, PLACED IN ONLAY FASHION, AND FIXATED USING SORBAFIX FASTENERS. MIDLINE FASCIA AND SKIN CLOSURE WAS ACHIEVED USING SUTURES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021. FROM (B)(6) 2021 TO (B)(6) 2023 PATIENT HAD MULTIPLE FOLLOW-UP VISITS. ON (B)(6) 2022, AN INCISIONAL HERNIA WAS NOTED. AT THIS TIME, THE INCISIONAL HERNIA WAS ASSESSED PER CLINICIAN AS NOT RELATED TO THE STUDY DEVICE. A PREVIOUS MRI ((B)(6) 2022) WAS REASSESSED; THERE WAS NO EVIDENCE OF A HERNIA. DURING A FURTHER VISIT ON (B)(6) 2023, THE PATIENT WAS REEXAMINED, AND IT WAS DETERMINED BY PHYSICAL EXAMINATION THAT A HERNIA WAS PRESENT, WITH DIFFERENT PRESENTATION FROM THE LAST VISIT ON (B)(6) 2022. THE INCISIONAL HERNIA HAS BEEN ASSESSED PER CLINICIAN AS MILD IN SEVERITY, DEFINITELY RELATED TO THE STUDY DEVICE AND THE PROCEDURE AND NOT RECOVERED/RESOLVED. THE REPORTED AE MEETS THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).

  Patient problems: Hernia

  MAUDE report 17511827 ↗
• InjuryMay 9, 2023Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  AS REPORTED PER THE CLINICAL TRIAL DVL-HE-018: THE SUBJECT PATIENT HAD AN OPEN MIDLINE UMBILICAL HERNIA REPAIR SURGERY ON (B)(6) 2011. THE SUBJECT PATIENT UNDERWENT AN OPEN PRIMARY LAPAROTOMY EPIGASTRIC AORTO-MESENTERIC BYPASS, DURING WHICH A BARD/DAVOL PHASIX MESH ONLAY (CAT NO #1191025 AND LOT NO # HUDZ2133) 4 X 10 RECTANGLE (10 X 25 CM) WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MULTIFILAMENT 3.0 VICRYL SUTURES. THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2021. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH AND THE MIDLINE FASCIA WAS COMPLETELY CLOSED. A 3CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. PROPHYLACTIC ANTIBIOTIC CLINDAMYCIN WERE USED PERIOPERATIVELY. SKIN CLOSURE WAS ACHIEVED WITH LONG-TERM ABSORBABLE SUTURE AND SURGICAL GLUE. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021. ON (B)(6) 2021 - THE PATIENT DIAGNOSED WITH ABDOMINAL PAIN, NAUSEA AND VOMITING AND WAS TREATED WITH MEDICATION. AS REPORTED, DEVIATION FROM PROTOCOL DEFINED PROCEDURE, RATIO OF SUTURE: LENGTH FOR FASCIAL CLOSURE DID NOT FALL WITHIN EXPECTED RANGE. THE REPORTED ADVERSE EVENT (ABDOMINAL PAIN, NAUSEA AND VOMITING) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY

  Patient problems: Abdominal Pain; Nausea; No Clinical Signs, Symptoms or Conditions; Vomiting

  MAUDE report 16899116 ↗
• InjurySep 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2021 - THE SUBJECT PATIENT UNDERWENT AN OPEN RESECTION OF A PELVIC MASS, DURING WHICH A BARD/DAVOL PHASIX MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MONOFILAMENT 2.0 VICRYL SUTURES. THE SURGERY WAS DONE WITHOUT TRIMMING THE PHASIX MESH AND THE MIDLINE FASCIA WAS COMPLETELY CLOSED. A 3CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. PROPHYLACTIC ANTIBIOTIC ROCEPHIN WERE USED PERIOPERATIVELY. SKIN CLOSURE WAS ACHIEVED WITH LONG-TERM ABSORBABLE SUTURE AND SURGICAL GLUE. IT WAS REPORTED THAT THE SUBJECT PATIENT WAS DIAGNOSED WITH ABDOMEN BULGING/HERNIA IN AUG-2022. AS REPORTED, THE SUBJECT PATIENT WILL UNDERGO SCAN ON (B)(6) 2022. AS REPORTED, THE REPORTED ADVERSE EVENT (ABDOMEN BULGE/HERNIA) HAS BEEN ASSESSED PER CLINICIAN AS DEFINITELY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE AND RECOVERING/RESOLVING. THE AE HAS BEEN ASSESSED AS MILD IN SEVERITY. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) OR UADE (UNANTICIPATED ADVERSE DEVICE EVENT).

  Patient problems: Hernia

  MAUDE report 15478144 ↗
• InjuryMay 26, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER PREVENT CLINICAL TRIAL DVL-HE-018: (B)(6). THE SUBJECT PATIENT UNDERWENT A PRIMARY LAPAROTOMY PROCEDURE TO PERFORM A CHOLEYEYSTOCOLONIC FISTULA TAKEDOWN, IN WHICH THE BARD/DAVOL PHASIX MESH WAS PLACED IN ONLAY FASHION. THE PHASIX MESH WAS NOT TRIMMED TO SIZE, WITH THE APPROPRIATE OVERLAP IN ALL DIRECTIONS BEYOND THE MARGINS OF THE FASCIAL INCISION. MECHANICAL FIXATION (BARD/DAVOL SORBAFIX) WAS USED TO FIXATE THE MESH. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH NON-BARD/DAVOL, 1PDS SLOW ABSORBING MONOFILAMENT SUTURES IN A RUNNING STITCH TECHNIQUE. SKIN CLOSURE WAS ACHIEVED USING LONG-TERM ABSORBABLE SUTURES. (B)(6) 2021, THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL. (B)(6) 2022, THE PATIENT EXPERIENCED A WOUND COMPLICATION WITH EXPOSURE OF THE PHASIX MESH. "WOUND IN THE DISTAL AREA IS APPROX. 4CM IN SIZE IN ORIGINAL INCISION, SCABBED OVER, BUT PATIENT STATES SCAB FALLS OFF AND RE-SCABS. MESH IS SLIGHTLY EXPOSED. WOUND IN PROXIMAL AREA APPROX. 3CM, NO MESH." THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED PER CLINICIAN AS DEFINITELY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. AS REPORTED, THE OUTCOME OF THE ADVERSE EVENT NOT RECOVERED/

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 14513674 ↗
• MalfunctionApr 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED (B)(4): ON (B)(6) 2021, PATIENT UNDERWENT A LAPAROSCOPIC COLECTOMY AND A BARD/DAVOL PHASIX MESH WAS TRIMMED AND PLACED IN ONLAY FASHION WITH A 3CM OVERLAP IN ALL DIRECTIONS. THE MESH WAS SUTURED IN PLACE WITH NON-BARD/DAVOL ABSORBABLE MONOFILAMENT SUTURES AND A BARD/DAVOL SORBAFIX FIXATION DEVICE. ON (B)(6) 2021, THE PATIENT WAS DIAGNOSED WITH INCISIONAL PAIN. THE PATIENT ALSO EXPERIENCED INCISIONAL SITE ITCHING IN (B)(6) 2021. THESE AES WERE REPORTED TO HAVE RESOLVED WITH NO TREATMENT PROVIDED, ON (B)(6) 2021. THE ADVERSE EVENTS HAVE BEEN ASSESSED AS MILD SEVERITY AND AS NOT A SERIOUS ADVERSE EVENT (SAE) OR AN UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) BY THE STUDY GROUP. THE ADVERSE EVENTS HAVE BEEN ASSESSED PER STUDY CLINICIAN AS NOT RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE ADVERSE EVENTS HAVE BEEN ASSESSED PER CEC CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE.

  Patient problems: Itching Sensation; Pain

  MAUDE report 14140610 ↗
• InjuryJun 21, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED SEROMA AND ABDOMINAL PAIN POST-IMPLANT OF PHASIX MESH. (B)(6) 2021 - THE SUBJECT PATIENT UNDERWENT AN OPEN RESECTION OF A PELVIC MASS. A BARD/DAVOL PHASIX MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MONOFILAMENT 2.0 VICRYL SUTURES. THE SURGERY WAS DONE WITHOUT TRIMMING THE BARD/DAVOL PHASIX MESH AND THE MIDLINE FASCIA WAS COMPLETELY CLOSED. A 3CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. SKIN CLOSURE WAS ACHIEVED WITH LONG-TERM ABSORBABLE SUTURE AND SURGICAL GLUE. (B)(6) 2021- THE SUBJECT PATIENT WAS DIAGNOSED WITH A POSTOPERATIVE SEROMA. PATIENT REPORTS HAVING ABDOMINAL PAIN SINCE INDEX SURGERY. PAIN BECAME SEVERE SO WENT TO LOCAL ED. AS REPORTED, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED PER CLINICIAN AS DEFINITELY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE AE HAS BEEN ASSESSED AS MODERATE IN SEVERITY. ADDENDUM PER ADDITIONAL INFORMATION: AS REPORTED, THE SEROMA WAS DRAINED ON (B)(6) 2021 VIA OUTPATIENT ULTRASOUND GUIDED DRAINAGE. THERE WAS NO OTHER ACTION TAKEN. IT WAS REPORTED THAT SEROMA WAS PREVIOUSLY THOUGHT TO BE RESOLVED BUT THE PET SCAN SHOWED

  Patient problems: Abdominal Pain; Seroma

  MAUDE report 12035007 ↗
• InjuryApr 30, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL PHASIX MESH. POSTOPERATIVELY THE PATIENT DEVELOPED A HEMATOMA AND WOUND DEHISCENCE. THE SURGEON REQUESTED A SURGEON TO SURGEON CONSULT, WHICH WAS GRANTED AND NEGATIVE PRESSURE WOUND THERAPY (NPWT) WAS RECOMMENDED TO TREAT THE PATIENT.

  Patient problems: Hematoma; Wound Dehiscence

  MAUDE report 8564891 ↗